Development of a Celiac Safe Food Additive: An Intervention Study in Healthy Volunteers
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Levels of deamidated gliadin peptides in blood
研究概览
简要总结
The goal of this clinical trial was to investigate if intestinal deamidation of gliadin from wheat bread could be hindered by adding a E304i/zinc additive. The study was a randomized double-blind 4-week crossover intervention in 20 healthy volunteers in which the participants ingested 2 bread rolls a day during the intervention weeks.
The question it aimed to answer was if there was a difference in blood levels of deamidated gliadin peptides after ingestion of the reference wheat bread compared with the wheat bread containing the food additive.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Supportive Care
- 盲法
- Double (Participant, Care Provider)
盲法说明
The participants did not know which bread was received; the bags were color-coded. The personnel meeting the participants did not know which color belonged to which bread. Only the principal investigator (and the bakery) not meeting participants knew which color belonged to which bread type.
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Signed informed consent
- •Body mass index between 18.5 to 32
- •Age between 18-50 years
- •No tobacco use
排除标准
- •Celiac disease and other diagnosed enteropathies
- •Gluten-free diet
- •Dietary supplementation (minerals (calcium, zinc, vitamin D) and proteolytic enzymes, probiotics)
- •Pregnancy or lactation
- •Lack of suitability for participation in the study, for any reason, as judged by the medical doctor or the project PI.
- •Withdrawn consent: Participant withdraws consent.
- •Non-compliance: Participant fails repeatedly to comply with study protocol (diet, study visits and provide samples)
结局指标
主要结局
Levels of deamidated gliadin peptides in blood
时间窗: Blood samples were drawn once weekly at day 7, 14, 21, 28
Deamidated gliadin peptides in blood measured by ELISA using an antibody towards deamidated gliadin peptides
次要结局
未报告次要终点
研究者
Nathalie Scheers
Associate professor
Chalmers University of Technology